Quality Engineer

Job Description

As a Quality Engineer, you will be responsible for supporting qualification documentation filing, preparation, and data collection. The role involves analytical assessment, documentation management, and thermocouple assembly/calibration. You will ensure compliance with cGMP standards and work closely with Validation Engineers and quality assurance document control.

Responsibilities

• Collect current equipment documentation to fill gaps or identify missing information, working with Validation Engineers and quality assurance document control.
• Support validation protocols for data collection or document creation as assigned.
• Assist with the execution of equipment validation studies, including protocol execution, data analysis, and control system administration such as software backups and system updates.
• Program and operate department analytical instruments, such as temperature/humidity dataloggers, to perform controlled temperature/humidity chamber qualifications.
• Draft commissioning and qualification protocols to demonstrate that the process is designed and fit for its intended use.
• Support ongoing system requalification and continuous improvement activities governed by change management processes.

Essential Skills

• Quality engineering
• Quality assurance
• Technical documentation
• Technical writing
• Troubleshooting
• Quality control
• Strong verbal and written communication skills
• Attention to detail
• Problem-solving skills
• Proficiency in Microsoft Office tools (Word, Excel)

Additional Skills & Qualifications

• Understanding of documentation organization, ideally in a GMP environment
• Basic mechanical skills
• Understanding of statistical analysis tools and/or analytical methods
• BS/BA Degree in science, engineering, manufacturing technology, or a closely related field, or equivalent experience in a manufacturing facility
• 0 - 2 years of pharmaceutical manufacturing experience

Work Environment

You will work in a lab/manufacturing environment, where you will engage with various analytical instruments and systems. The role requires adherence to safety standards and compliance with regulatory guidelines.

Pay and Benefits

The pay range for this position is $23.00 - $25.00/hr.

Eligibility requirements apply to some benefits and may depend on your job

classification and length of employment. Benefits are subject to change and may be

subject to specific elections, plan, or program terms. If eligible, the benefits

available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Grand Island,NY.

Application Deadline

This position is anticipated to close on Jul 14, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.